Polysorbate 80 (E433) Sodium chloride Hydrochloric acid (for pH adjustment) Solvent Water for injections 6.2 Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 6.3 Shelf life The expiry date of the powder (antigens) and solvent is indicated on the label and packaging. The unopened vial of powder (antigens) is stable for 5 days when stored at temperatures from 8 °C to 30 °C. At the end of this period the vial of powder should be used or discarded. This information is used to guide healthcare professionals in case of temporary temperature excursions only.
Vaccine Vial Monitor The Vaccine Vial Monitor (VVM) is part of the cap used for all Abrysvo batches supplied by Pfizer Europe MA EEIG. The colour dot that appears on the cap of the vial of powder (antigens) is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level. Figure 1: How to read a Vaccine Vial Monitor The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively.
As long as the colour of this square is lighter than the colour of the ring, then the vaccine can be used. As soon as the colour of the central square is the same colour as the ring or of a darker colour than the ring, then the vial should be discarded. 11